Phase III ELARIS UF-I study of elagolix meets primary endpoint in uterine fibroids.- AbbVie.

AbbVie announced that the Phase III ELARIS UF-I study (M12-815) of elagolix met its primary endpoint. Results from the first of two pivotal Phase III studies demonstrated at month six that elagolix, in combination with low-dose hormone (add-back) therapy, reduced heavy menstrual bleeding with 68.5 percent (p<0.001) of women with uterine fibroids achieving clinical response compared to placebo 8.7 percent as measured by the alkaline hematin method. clinical response was defined as menstrual blood loss volume of less than 80 ml during month six and a 50 percent or greater reduction in menstrual blood loss volume from baseline to month six. the study also met all ranked secondary endpoints p><0.001) at month six.>

Hypoestrogenic effects, such as hot flush and reduction in bone mineral density, from elagolix treatment were observed in the study. In addition, the overall safety profile for elagolix was consistent with what was observed in Phase II studies in uterine fibroids. Data from the Phase III study will support regulatory submissions for elagolix and will be presented at an upcoming medical conference. Safety data, including most common adverse events, are currently being analyzed. The topline results are from a six-month primary analysis. Women in the study will continue in either post-treatment follow-up or a blinded six-month extension study.

Comment: Treatment options for uterine fibroids include surgery (hysterectomy, myomectomy), hysteroscopy, endometrial ablation, uterine artery embolization, magnetic resonance imaging-guided ultrasound and medical management with treatments such as oral contraceptives, progestins, selective progesterone receptor modulators, and GnRH agonists, some of which are not specifically indicated for the treatment of uterine fibroids.